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A Golden Ticket That Fast Tracks A Drug Through The FDA

Drugmaker Sarepta Therapeutics won a big victory when its $300,000 muscular dystrophy drug was recently approved, but the company had other reasons to celebrate, too. They were also awarded the drug w...
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Six Wall Street Analysts on What's Next for the Sarepta Duchenne Drug Story

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Sarepta Therapeutics and its backers endured an emotional FDA advisory committee meeting for eteplirsen, its Duchenne Muscular Dystrophy Drug. The Cambridge, Mass.-based company failed to win the expert recommendation it was seeking...

Approving Sarepta's Muscular Dystrophy Drug Could Force FDA To Get Creative

Business & Finance : Forbes: Business

The Food and Drug Administration is delaying what will probably be the most controversial decision it will make this year. But what does that delay mean? Sarepta Therapeutics, a start-up firm developing a drug called eteplirsen for ...

Sarepta's keenly watched muscle dystrophy drug wins FDA approval

Health : Reuters: Health

(Reuters) - Sarepta Therapeutics Inc's Duchenne muscular dystrophy drug won approval from the U.S. Food and Drug Administration on Monday, capping months of regulatory uncertainty and pressure from parents and patient advocates to e...

Now That FDA Has Approved Muscular Dystrophy Drug Against Advisors' Recommedation, What's Next?

Business & Finance : Forbes: Business

Against its advisory committee's advice, the FDA on Monday approved the first drug to treat Duchenne muscular dystrophy, although it warned that it could withdraw the drug if Sarepta Therapeutics doesn't provide conclusive evidence ...

Sarepta Wins FDA Nod For Embattled DMD Drug -- But With A Catch

Business & Finance : Forbes: Business

Just five days after its main nemesis at the FDA departed the agency, Sarepta Therapeutics has won a long-sought-after approval for eteplirsen, its drug to treat Duchenne muscular dystrophy (DMD). But the company's battle isn't over...


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